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CVS applauds FTC report on biologics competition
June 12th, 2009
Dave Golding, CVS Caremark
WOONSOCKET, R.I. – CVS Caremark Corp. gave kudos to a new Federal Trade Commission report that calls for the creation of an efficient pathway for bringing follow-on biologic (FOB) drugs to market, in turn making biologics more affordable for consumers.
The company said the FTC report takes a pro-consumer stance and "reasonably balances innovation with competition."
"CVS Caremark serves hundreds of thousands of patients who rely on specialty and other biologic medicines to provide life-saving treatments for their conditions," Dave Golding, executive vice president for specialty pharmacy services at CVS Caremark, said in a statement. "The FTC's expertise and their findings in support of a legislative pathway allowing the Food and Drug Administration to approve biogenerics in light of market-based competition that drives innovation should be heeded by Congress as we consider health care reform."
Golding participated in an FTC roundtable event on the issue last fall. The company also has provided the FTC with data to assist in its research.
"CVS Caremark supports the Promoting Innovation and Access to Life-Saving Medicine Act because it represents bipartisan legislation that seeks to give patients access to safe and affordable medicines, even while fostering pharmaceutical innovation," Golding commented. "Increased competition in the biologics market will benefit health plans, employers and federal programs and, more importantly, will help make these medicines more affordable for patients, many of whom must take these medicines for their entire lives."
The FTC report, titled “Follow-on Biologic Drug Competition,” looks at whether the price of biologics — made using living tissues and microorganisms — could be reduced by competition from FOBs, which are like generic drugs but with key differences.
Biologics are increasingly being prescribed for the treatment of arthritis, cancer, diabetes and other diseases, the report finds, yet no pathway now exists for such FOBs to enter the market and compete with their pioneer counterparts.
The FTC notes that biologics are costly, even more than branded versions of most traditional “small-molecule” drugs. For example, the annual treatment with the biologic Herceptin, used to treat breast cancer, can run $48,000.
If brought to market, FOBs could cut the estimated $40.3 billion a year that consumers spend on biologics, according to the commission. The report concludes that giving the FDA the authority to approve FOBs would be an efficient way to bring these lower-priced drugs to market.
“If Congress creates an efficient pathway to follow-on biologic drugs and, at least as important, ends ‘pay-for-delay’ pharmaceutical settlements that delay entry of traditional generic drugs, it will be taking a major step forward for both health care reform and affordable drugs for all Americans,” FTC chairman Jon Leibowitz stated.